Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1525965.
Observations14
Issue DateMarch 02, 2018
StatusNo Warning Letter
Establishment TypeMedical Device Manufacturer
Related Inspections10
Establishment Details
Firm
Philips Medical Systems (Cleveland) Inc
Location
Cleveland, Ohio, United States
FEI Number
1525965
Establishment Type
Medical Device Manufacturer
Product Type
Devices
Issue Date
March 02, 2018
Country
United States
Inspection History, 2008 to 2019
NAI1
VAI7
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.